Follow-on biologics are fast becoming a reality in global pharmaceutical markets. The passing of the 2010 Healthcare Reform Act defines the framework and exclusivity rules concerning biosimilars in the US, and is expected to fuel increased activity in this important area for generics, traditional small-molecule focused innovators, and biotech companies.
The Newport Biologics Module contains unique manufacturing process data covering biologic drugs. Companies considering pursuing biosimilar opportunities can analyze multiple potential
bio-manufacturing processes for each drug, genetic sequences, process steps, starting materials, and equipment required, as well as review related patents and literature references. Also included is US BLA (Biologics License Application) data for drugs approved through this regulatory route.
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